Losartan Potassium Tablets USP 50 mg 50 Tablets recall: Impurity Out of Spec
Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15
Why was Losartan Potassium Tablets USP 50 mg 50 Tablets recalled?
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: 20961 Exp. 09/2019; 20477 Exp. 08/2019
- Product
- Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15
- Recalling firm
- AVKARE Inc.
- Quantity
- N/A
- Distribution
- Nationwide.
- Recall date
- March 27, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)